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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006636
Receipt No. R000007851
Scientific Title Occlusive/Stenotic Peripheral artery REvascularization studY for LONG stent
Date of disclosure of the study information 2011/11/03
Last modified on 2014/04/30

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Basic information
Public title Occlusive/Stenotic Peripheral artery REvascularization studY for LONG stent
Acronym OSPREY-LONG
Scientific Title Occlusive/Stenotic Peripheral artery REvascularization studY for LONG stent
Scientific Title:Acronym OSPREY-LONG
Region
Japan

Condition
Condition Peripheral arterial disease of lower extremities by a stenotic or occlusive de novo lesion at SFA/PA
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this study is to confirm the safety and efficacy of the Longer size of Misago in a stenotic or occlusive de novo lesion at SFA/PA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Non-TLF rate within 30 days
Key secondary outcomes Delivery success, Lesion success, Patency rate, Acute Gain, ABI, Rutherford classification, QoL,
Adverse events, Serious adverse events, Major adverse events, Device failures/Malfunctions including stent fracture, Complications relate to investigational devices

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Stent
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)20 years of age and older, (on the signature date of the consent form)
(2) Informed consent
(3) Rutherford classification (category 2, 3 or 4)
(4) Resting ABI of <0.9, or exercise ABI falls by more than 0.1
(5) Reference vessel diameter of target lesion is &#8805;4.0 mm and &#8804;6.0 mm
(6) Target lesion length is &#8804;150 mm. The target lesion should be treatable with one stent.
Key exclusion criteria (1) Patients with terminal illness in whom life expectancy is expected to be less than 1 years
(2) Patients who are participating in other clinical study of medical device or pharmaceuticals within 3months before registration
(3) Patients who already participated in this study in the past.
(4) Patients who previously received a bypass surgery, stent implantation or any surgery at SFA or distally
(5) Scheduled for a staged procedure to treat lesions within the aorta or ipsilateral run-off vessels after enrollment
(6) Patients who have allergy or experienced an anaphylactic symptom to components (Nitinol, gold etc.) of the study device
(7) Patients with acute or chronic renal dysfunction (serum creatinine value is 2.0 mg/dL or greater)
(8) Patients with advanced calcification or excessive tortuosity at target lesion detected by DUS/angiography
(9) Patients who are pregnant or breast-feeding, or in whom these conditions are possible
(10) Patients who were judged to be inappropriate for participation in the study due to severe or uncontrolled systemic disease of any condition by the principal investigators/investigators.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Iida
Organization Kansai Rosai Hospital
Division name Cardiovascular center
Zip code
Address 3-1-69 inabasou amagasaki-shi, Hyougo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Ogata
Organization Terumo Corporation
Division name Clinical Development Department
Zip code
Address 1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
TEL
Homepage URL
Email

Sponsor
Institute Terumo Corporation
Institute
Department

Funding Source
Organization Terumo Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 31 Day
Last modified on
2014 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007851

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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